The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.

Sponsor
Heartfulness Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05874232
Collaborator
(none)
203
1
2
4.9
41.2

Study Details

Study Description

Brief Summary

This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-Care Program through Heartfulness
N/A

Detailed Description

The specific aim of this study is to assess changes in scores measuring symptoms of anxiety using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA Loneliness Scale (Version 3).

Study Design

Study Type:
Interventional
Actual Enrollment :
203 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
Actual Study Start Date :
Feb 3, 2022
Actual Primary Completion Date :
Jun 3, 2022
Actual Study Completion Date :
Jul 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Heartfulness Group

Participants were asked to practice relaxation tools for 15 minutes a day using the calendar and HeartBot app, and participate in once a weekly webinar for 30 minutes during the four weeks. The GAD, SWLS, and UCLA Loneliness scale was recorded prior to the start of the study, at the end of the program at Week 4, and after the duration of 4 weeks at Week 8. The score was reviewed to see the changes in anxiety, satisfaction with life, and loneliness scale.

Behavioral: Self-Care Program through Heartfulness
A four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a weekly webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute.

No Intervention: Control Group

The control group had no change in their daily routines.

Outcome Measures

Primary Outcome Measures

  1. Assess the current level of Anxiety [Week 0]

    To assess the current level of anxiety in high school students and staff through GAD Scale.

  2. Changes level of Anxiety [Week 4 and Week 8]

    To assess the beneficial impact of Heartfulness program on anxiety in high school students and staff.

  3. Assess the current level of Satisfaction with Life [Week 0]

    To assess the current level of satisfaction with life in high school students and staff through SWLS Scale.

  4. Changes level of Satisfaction with Life [Week 4 and Week 8]

    To assess the beneficial impact of Heartfulness program on satisfaction with life in high school students and staff.

  5. Assess the current level of Loneliness [Week 0]

    To assess the current level of loneliness in high school students and staff through UCLA loneliness scale.

  6. Changes in Loneliness levels [Week 4 and Week 8]

    To assess the beneficial impact of Heartfulness program on loneliness in high school students and staff.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study.
Exclusion Criteria:
  • Non-English speaking high school students and staff and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ranjani B Iyer Novi Michigan United States 48375

Sponsors and Collaborators

  • Heartfulness Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heartfulness Institute
ClinicalTrials.gov Identifier:
NCT05874232
Other Study ID Numbers:
  • 2022/01/2
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2023